Efficacy of Ultrasound-Guided Genicular Nerve Block in Patients With Gonarthrosis: A Randomized, Placebo-Controlled, Double-Blind Study

NCT ID: NCT07326098

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-12-01

Brief Summary

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This study planned to enroll a minimum of 30 patients aged 50 years and older, with a diagnosis of gonarthrosis classified as stage 2 or higher according to the Kellgren-Lawrence grading system, and who report complaints of knee pain and walking difficulties. Patients will be randomized into two groups, and they will be blinded to the group to which they are assigned.

In the first group, ultrasound-guided genicular nerve block will be performed using a combination of lidocaine and triamcinolone hexacetonide injection (4 mL Priloc 2% + 1 mL Artropan 20 mg). In the second group, a placebo injection (5 mL saline solution) will be administered. Both groups will be instructed to follow an appropriate exercise program after the treatment.

Patients will undergo a detailed physical examination, 6-minute walk test, VAS pain score, WOMAC questionnaire, and 3D kinematic gait analysis with pressure parameters evaluated by a blinded researcher. Evaluations will take place before treatment, 1 hour after treatment, and 1 month post-treatment.

The collected data will be analyzed for differences between the two groups and changes over time. The potential positive effects of the treatment will be measured and compared with the placebo group to assess the therapeutic efficacy.

Detailed Description

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In addition to the fact that genicular nerve block is highlighted in the literature as a potential alternative to surgery, it is also crucial to consider the reality that the pain symptoms in these patients have a more significant negative impact on walking than initially expected, potentially creating a comorbidity of its own. Given this, this study aims to contribute to the medical literature by observing the improvement in walking parameters secondary to the reduction of pain symptoms in patients with gonarthrosis.

Conditions

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Gonarthrosis; Primary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The study is conducted as a randomized, double-blind, placebo-controlled trial. Both participants and care providers administering the injections are blinded to group assignments. Syringes are prepared and covered by an independent researcher to ensure identical appearance across groups

Study Groups

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İntervention group

Ultrasound-guided genicular nerve block will be performed using a combination of 4 mL Priloc 2% (lidocaine) and 1 mL Artropan 20 mg (triamcinolone hexacetonide).

The syringe's outer part will be covered by an independent researcher to conceal the contents.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

Group Type EXPERIMENTAL

genicular nerve block

Intervention Type PROCEDURE

Genicular nerve block performed with pharmacological agents under ultrasound guidance is minimally invasive compared to other block techniques. It can be carried out in an outpatient setting with attention to sterility, does not involve radiation, does not require procedural surgical preparations, and is less costly both for the patient and the healthcare system. Furthermore, it has fewer side effects, with many studies reporting no side effects at all.

Placebo group

A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions.

The syringe's outer part will be covered by an independent researcher to conceal the contents.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

Group Type PLACEBO_COMPARATOR

Placebo injection (normal saline)

Intervention Type PROCEDURE

A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions as the active group.

The syringe will be covered by an independent researcher to conceal the contents, ensuring identical appearance across groups.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

Interventions

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genicular nerve block

Genicular nerve block performed with pharmacological agents under ultrasound guidance is minimally invasive compared to other block techniques. It can be carried out in an outpatient setting with attention to sterility, does not involve radiation, does not require procedural surgical preparations, and is less costly both for the patient and the healthcare system. Furthermore, it has fewer side effects, with many studies reporting no side effects at all.

Intervention Type PROCEDURE

Placebo injection (normal saline)

A placebo injection with 5 mL saline solution will be administered under the same sterile and ultrasound-guided conditions as the active group.

The syringe will be covered by an independent researcher to conceal the contents, ensuring identical appearance across groups.

All participants will also perform a home exercise program: quadriceps strengthening and knee isometric exercises.

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound-guided genicular nerve block including the combination of lidocaine and triamcinolone hexacetonide

Eligibility Criteria

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Inclusion Criteria

* Knee pain persisting for 3 months or longer
* Diagnosis of gonarthrosis with Grade 2 or higher tibiofemoral osteoarthritis detected on plain radiographs
* Patients aged 50 years and older
* Continued pain despite conservative treatment (exercise, simple analgesics such as paracetamol, or nonsteroidal anti-inflammatory drugs)

Exclusion Criteria

* Clinical diagnoses that could cause knee pain other than gonarthrosis (rheumatologic diseases, secondary osteoarthritis, fractures, etc.)
* Signs of inflammation/exacerbation
* Infection at the injection site or skin lesions
* Diagnosis of malignancy
* Gait impairment (the patient must be able to ambulate independently)
* Known allergy to study medications
* Previous knee surgery
* Uncontrolled comorbid conditions such as diabetes mellitus or hypertension, which contraindicate corticosteroid use
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ece Cinar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ece Cinar, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

EGE UNİVERCİTY

Locations

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Ege University Faculty of Medicine

Izmir, Bornova, Turkey (Türkiye)

Site Status RECRUITING

Ege University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sanem Cesur, Sub-Investigator

Role: CONTACT

+905336834303

Ece Cinar, Assistant Professor

Role: CONTACT

+905372257018

Facility Contacts

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Ece Cinar, MD, Assistant Professo

Role: primary

+905372257018

Sanem Cesur, MSc (Sub-Investigator)

Role: backup

+905336834303

Ece Cinar, MD, Assistant Professor

Role: primary

+905372257018

Sanem Cesur, PT, MSc (Sub-Investigator)

Role: backup

+905336834303

References

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Lebleu J, Fonkoue L, Bandolo E, Fossoh H, Mahaudens P, Cornu O, Detrembleur C. Lower limb kinematics improvement after genicular nerve blockade in patients with knee osteoarthritis: a milestone study using inertial sensors. BMC Musculoskelet Disord. 2020 Dec 7;21(1):822. doi: 10.1186/s12891-020-03836-8.

Reference Type RESULT
PMID: 33287783 (View on PubMed)

Other Identifiers

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25-5.1/20

Identifier Type: -

Identifier Source: org_study_id

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